Efficacy and Safety of Escitalopram in Patients With Generalized Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)
研究概览
简要总结
The purpose of this study is to evaluate the effect of escitalopram after 8 weeks of treatment in patients with Generalized Anxiety Disorder (GAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.
详细描述
The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 8 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characteristics (SPC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient suffers from GAD, diagnosed according to ICD-10 (International Classification of Diseases)
- •The patient meets criteria as set out in the national SPC for escitalopram
- •The patient is, in the opinion of the investigator, otherwise healthy on the basis of a physical examination, medical history and vital signs
排除标准
- •The patient has/has had an alcohol or drug abuse-related disorder, as defined in ICD-10
- •The patient has contraindications to escitalopram
- •The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram
- •The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance
- •The patient is pregnant or breast-feeding
- •The patient, if a woman of childbearing potential, is not using adequate contraception
研究组 & 干预措施
Escitalopram
干预措施: Escitalopram (Drug)
结局指标
主要结局
Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)
时间窗: baseline and 8 weeks
The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.
次要结局
- Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)(baseline and 8 weeks)
- Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)(baseline and 8 weeks)
- Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2(baseline and 8 weeks)
- Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2(baseline and 8 weeks)
- Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work(baseline and 8 weeks)
- Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family(baseline and 8 weeks)
- Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social(baseline and 8 weeks)
- Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score(baseline and 8 weeks)